HIV-1 Virologic Suppression With TMB-365 and TMB-380 Antibodies Study
NCT ID: NCT07215468
Last Updated: 2026-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
75 participants
INTERVENTIONAL
2025-12-16
2027-08-31
Brief Summary
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Researchers will compare TMB-365/TMB-380 given IV every 8 weeks to continuation of daily oral cART to see if TMB-365/TMB-380 can also maintain viral suppression.
Participants will:
1. Receive TMB-365/TMB-380 infusion or take oral cART as scheduled for 48 weeks
2. Visit the clinic as schedule for checkups and tests
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Combination of TMB-365 and TMB-380 antibodies via IV infusions
Participants will receive an IV infusion of the combination of TMB-365 and TMB-380 each every 8 weeks.
TMB-365
A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously
TMB-380
A broadly neutralizing antibody (bNAb) against HIV to be given intravenously
Baseline oral cART
Participants will continue suppressive daily oral cART
Baseline ART
Baseline ART to be taken daily and orally
Interventions
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TMB-365
A monoclonal antibody acts as a HIV post-attachment inhibitor to be given intravenously
TMB-380
A broadly neutralizing antibody (bNAb) against HIV to be given intravenously
Baseline ART
Baseline ART to be taken daily and orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Asymptomatic HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by Geenius™ or a second antibody test by a method other than the initial rapid HIV and/or E/CIA test, or by HIV-1 antigen, plasma HIV-1 RNA viral load at or prior to screening.
3. On continuous suppressive cART for at least 6 months prior to Screening with one documented HIV-1 RNA level \<50 copies/mL within 6 months of Screening. Continuous cART is defined as no interruptions greater than 3 consecutive days. cART is defined as a DHHS recommended regimen. Study participants should be on a stable oral regimen for at least 3 months prior to Screening.
4. Screening plasma HIV-1 RNA \< 50 copies/mL
5. CD4+ T cell count \>350 cells/mm3
6. Laboratory values obtained within 35 days prior to the first dose:
* Hemoglobin ≥ 10.0 g/dL
* Platelet count ≥ 100,000/mm3
* Absolute neutrophil count ≥ 1,000/mm3
* Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 1.5 x upper limit of normal (ULN)
* Creatinine clearance (CrCl) of ≥ 50 mL/min
7. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
8. In the opinion of the principal investigator or designee, has understood the information provided; written informed consent needs to be given before any study-related procedures are performed.
9. Persons of childbearing potential sexually active with a partner who can impregnate them, must agree to use one effective method of contraception from the time of signing the consent to completion of the study, and agree to pregnancy testing as per the Schedule of Events and Procedures. Persons of childbearing potential are participants born female who are not surgically sterile (no history of bilateral tubal ligation, hysterectomy, or bilateral salpingo-oophorectomy), are not postmenopausal (at least one year without menses), and are not otherwise sterile by medical evaluation.
Exclusion Criteria
2. Receiving cabotegravir and rilpivirine intramuscularly as maintenance therapy for HIV-1 infection.
3. Pregnant, planning a pregnancy during the trial period, or lactating.
4. Known allergy/sensitivity or any hypersensitivity to components of the study drug or its formulation, or known allergy to a MAb.
5. History of severe allergic reactions to medications, vaccinations, or monoclonal antibody therapy for other conditions such as COVID.
6. Major psychiatric illness including any history of schizophrenia or severe psychosis, uncontrolled bipolar disorder requiring acute therapy, or suicide attempt in the previous three years.
7. Serious illness requiring systemic treatment and/or hospitalization within 21 days prior to Baseline.
8. Receipt of immunomodulatory agents (e.g., interleukins, interferons, cyclosporine, high dose systemic corticosteroids), HIV vaccine, systemic cytotoxic chemotherapy, or investigational therapy within 180 days prior to Baseline.
9. Any chronic or acute medical condition, including chronic Hepatitis B infection, chronic Hepatitis C infection with viremia, drug use and alcohol abuse, which in the opinion of the investigator would interfere with evaluation of the study drug.
10. Lack of adequate venous access.
11. Individuals who have experienced virologic failure during treatment with two or more cART treatment regimens and those being treated with regimens containing either ibalizumab, enfuvirtide, maraviroc, or fostemsavir. Note that a change in treatment regimen for intolerance does not meet criteria for treatment failure.
18 Years
ALL
No
Sponsors
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TaiMed Biologics Inc.
INDUSTRY
Responsible Party
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Locations
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Long Beach Education and Research Consultants
Long Beach, California, United States
Quest Clinical Research
San Francisco, California, United States
CAN Community Health Fort Lauderdale
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center (MIRC)
Ft. Pierce, Florida, United States
CAN Community Health Miami Gardens
Miami Gardens, Florida, United States
Midland Medical
Oakland Park, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
CAN Community Health Sarasota
Sarasota, Florida, United States
Mercer University, Department of Internal Medicine, Clinical Research
Macon, Georgia, United States
CAN Community Health Las Vegas
Las Vegas, Nevada, United States
The Crofoot Research Center, Inc.
Houston, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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TMB-b21
Identifier Type: -
Identifier Source: org_study_id
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